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SONATA (ZALEPLON): ADVERSE REACTIONS, SIDE EFFECTS

The premarketing development program for Sonata included zaleplon exposures in patients and/or normal subjects from 2 different groups of studies: approximately 900 normal subjects in clinical pharmacology/pharmacokinetic studies; and approximately 2,900 exposures from patients in placebocontrolled clinical effectiveness studies, corresponding to approximately 450 patient exposure years. The conditions and duration of treatment with Zaleplon (Sonata) varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Adverse Events Associated With Discontinuation of Treatment

In premarketing placebo-controlled, parallel-group phase 2-3 clinical trials, 3.1% of 801 patients who received placebo and 3.7% of 2,149 patients who received Sonata discontinued treatment because of an adverse clinical event. This difference was not statistically significant. No event that resulted in discontinuation occurred at a rate of >= 1%.

Adverse Events Occurring at an Incidence of 1% or More Among Sonata 20 mg-Treated Patients

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Other Adverse Events Observed During the Premarketing Evaluation of Sonata (Zaleplon) capsules

Listed below are COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the Adverse Reactions section. These events were reported by patients treated with Sonata at doses in a range of 5 to 20 mg/day during premarketing phase 2 and 3 clinical trials throughout the United States, Canada, and Europe including approximately 2,900 patients. All reported events are included except those already listed in Table 1 or elsewhere in labeling, those events for which a drug cause was remote, and those event terms that were so general as to be uninformative. It is important to emphasize that although the events reported occurred during treatment with Sonata, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients.

Body as a whole - Frequent: chest pain, back pain, fever; Infrequent: chills, chest pain substernal, face edema, hangover effect, generalized edema, neck rigidity.

Cardiovascular system - Frequent: migraine; Infrequent: bundle branch block, angina pectoris, hypertension, palpitation, hypotension, syncope, vasodilatation, tachycardia, ventricular extrasystoles; Rare: cerebral ischemia, bigeminy, cyanosis, postural hypotension, pericardial effusion, pulmonary embolus, thrombophlebitis, sinus bradycardia, ventricular tachycardia.

Digestive system - Frequent: dry mouth, constipation, dyspepsia; Infrequent: esophagitis, eructation, flatulence, gastroenteritis, gastritis, gingivitis, increased appetite, glossitis, mouth ulceration, melena, rectal hemorrhage, stomatitis; Rare: biliary pain, aphthous stomatitis, bruxism, cheilitis, cardiospasm, cholelithiasis, dysphagia, duodenal ulcer, enteritis, increased salivation, gum hemorrhage, intestinal obstruction, peptic ulcer, liver function tests abnormal, tongue discoloration, ulcerative stomatitis, tongue edema.

Endocrine system - Rare: goiter, diabetes mellitus, hypothyroidism.

Hemic and lymphatic system - Infrequent: ecchymosis, anemia, lymphadenopathy; Rare: leukocytosis, eosinophilia, lymphocytosis, purpura.

Metabolic and nutritional - Infrequent: gout, edema, hypercholesteremia, weight gain, thirst; Rare: hyperglycemia, bilirubinemia, hyperuricemia, hypoglycemic reaction, hypoglycemia, ketosis, AST (SGOT) increased, ALT (SGPT) increased, lactose intolerance, weight loss.

Musculoskeletal system - Frequent: arthritis, arthralgia, myalgia; Infrequent: bursitis, arthrosis, joint disorder (stiffness, mainly swelling, and pain), myasthenia, tenosynovitis; Rare: osteoporosis, myositis.

Nervous system - Frequent: depression, anxiety, nervousness, thinking abnormal (mainly difficulty concentrating); Infrequent: agitation, abnormal gait, apathy, circumoral paresthesia, ataxia, emotional lability, hyperesthesia, euphoria, hyperkinesia, incoordination, hypotonia, insomnia, neuralgia, libido decreased, nystagmus; Rare: delusions, CNS stimulation, dysarthria, facial paralysis, dystonia, hostility, myoclonus, hypokinesia, neuropathy, ptosis, psychomotor retardation, reflexes decreased, sleep talking, reflexes increased, sleep walking, stupor, slurred speech, trismus.

Respiratory system - Frequent: bronchitis; Infrequent: dyspnea, asthma, laryngitis, snoring, pneumonia, voice alteration; Rare: hiccup, apnea, hyperventilation, sputum increased, pleural effusion.

Skin and appendages - Frequent: rash, pruritus; Infrequent: alopecia, acne, contact dermatitis, eczema, dry skin, maculopapular rash, sweating, skin hypertrophy, urticaria, vesiculobullous rash; Rare: melanosis, pustular rash, psoriasis, skin discoloration.

Special senses - Frequent: taste perversion, conjunctivitis; Infrequent: dry eyes, diplopia, photophobia, watery eyes, tinnitus; Rare: blepharitis, abnormality of accommodation, cataract specified, deafness, corneal erosion, eye hemorrhage, labyrinthitis, glaucoma, retinal detachment, visual field defect, taste loss.

Urogenital system - Infrequent: breast pain, bladder pain, cystitis, hematuria, decreased urine stream, dysuria, impotence, kidney pain, kidney calculus, menorrhagia, metrorrhagia, urinary incontinence, urinary frequency, urinary urgency, vaginitis; Rare: delayed menstrual period, albuminuria, leukorrhea, urethritis, menopause, urinary retention, vaginal hemorrhage.

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